US2016331693A1PendingUtilityA1

All natural, non-toxic sublingual drug delievery systems

Assignee: SCILABS PHARMACEUTICALSPriority: Feb 7, 2014Filed: Mar 7, 2014Published: Nov 17, 2016
Est. expiryFeb 7, 2034(~7.5 yrs left)· nominal 20-yr term from priority
Inventors:Paul Edalat
A61P 15/10A61K 9/4808A61K 47/30A61K 9/0056A61K 45/06A61K 9/006A61K 9/48A61K 9/4825A61K 47/38A61K 47/12A61K 47/02A61K 9/2095A61K 9/2072A61K 9/2004A61K 9/0002A61J 3/10
57
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Claims

Abstract

All natural non-toxic sublingual delivery systems improve absorption and onset profiles for numerous actives, along with bioavailability and pharmacokinetics results that are better than expected for families of moieties compounds and legacy-patented formulations.

Claims

exact text as granted — not AI-modified
1 . A method for enhancing absorption and bioavailability of medically active or palliative ingredients comprising compounds or pharmaceutically acceptable salts thereof, said method further comprising, in combination:
 ascertaining minimal dosage and required dissolution environments for select medicaments;   entabulating resultory aliquots within sublingual delivery vehicles; and,   creating said resultant products whereby bioavailability is enhanced.   
     
     
         2 . A process for enhancing absorption of a medicament suitable for transmucosal/sublingual administration which comprises, in combination:
 providing shape-enhanced delivery vehicles;   matching selected pharmacokinetic profiles with time-based delivery enhancers; and,   optimizing flux of ionized and non-ionized forms of compounds, across mucous membranes.   
     
     
         3 . A novel enhanced continuous sublingual capsule extrusion process, which comprises, in combination:
 extruding at least an eccentric gelatin capsule case;   extruding at least a gelatin plug set;   filling the extrudates; and,   plugging the same with respective gelatin plugs;   whereby the process is continuous, capsule diameter sets with extrusion die;
 the length of capsule is determined by a final cutting step; and, 
 the eccentric nature of capsules provides for a thin wall to enable dissolution with additional processing. 
   
     
     
         4 . Products, by the method of  claim 1 , comprising:
 at least one of pulmonary hypertension agents, vasodilators, cholesterol management tools, and agents for treating blood pressure.   
     
     
         5 . A continuous offset extruded gel strip process, comprising, in combination:
 extruding at least an offset gelatin strip;   extruding at least pairing sets of gelatin plugs;   extruding the filling; and,   finishing the tablet/capsule with the gelatin cap extrusions.   
     
     
         6 . The process of  claim 5 , which is continuous, has strip dimensions set with extrusion dies;
 wherein the strip is cut to a desired length at end of process; and,   the offset strip causes dissolution of the thin wall to enable further processes.   
     
     
         7 .- 9 . (canceled) 
     
     
         10 . A process for manufacturing a sublingual bubbled gel strip with gelatin-ingredient mixture, which comprises, in combination:
 continuous manufacturing using a compressed air injection in gelatin-ingredient mixture;   controlling bubble-strip rope diameter;   mixing desired ingredients; and,   finishing.   
     
     
         11 . Products by the process of  claim 10 , including means for effervescently eluting actives over time. 
     
     
         12 . Products by the process of  claim 10 , wherein the textured surface reduces movement under the tongue. 
     
     
         13 . Products by the process of  claim 11 , having lower dissolution profiles temporally. 
     
     
         14 . Products by the process of  claim 11 , having higher bioavailability than expected within 1-7 minute windows of time. 
     
     
         15 . Products by the process of  claim 12 , to treat pulmonary hypertension, cholesterol, diabetes, cardiovascular disease, and pain. 
     
     
         16 . Products by the process of  claim 12 , whereby delivery of active ingredients produces pharmokinetic profiles of bioavailability with unexpectedly better results than known pharmaceuticals, supplements, and nutraceuticals.

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